Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2185-2015 | Class II | Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2184-2015 | Class II | Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2183-2015 | Class II | Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2182-2015 | Class II | Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2181-2015 | Class II | Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2180-2015 | Class II | Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2179-2015 | Class II | Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2178-2015 | Class II | Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2177-2015 | Class II | Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2176-2015 | Class II | Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2175-2015 | Class II | Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2174-2015 | Class II | Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2101-2015 | Class II | Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended... | Cook Incorporated | DYB | |
| Z-2100-2015 | Class II | Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular... | Cook Incorporated | GBZ | |
| Z-2173-2015 | Class II | Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2172-2015 | Class II | Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2171-2015 | Class II | 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2170-2015 | Class II | Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2169-2015 | Class II | Fiber Stripper, 910m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2168-2015 | Class II | Fiber Stripper, 550m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2167-2015 | Class II | Fiber Stripper, 365m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2166-2015 | Class II | Fiber Stripper, 273m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2165-2015 | Class II | Fiber Stripper, 200m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2164-2015 | Class II | Fiber Stripper, 150m, Autoclavable; The Fiber Stripper is a tool provided for stripping... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2163-2015 | Class II | 365M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2162-2015 | Class II | 200M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2161-2015 | Class II | Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2160-2015 | Class II | Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2159-2015 | Class II | Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2158-2015 | Class II | Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2157-2015 | Class II | Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2156-2015 | Class II | Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in... | American Medical Systems Innovation Center - Silicon Valley | GEX | |
| Z-2092-2015 | Class II | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA... | Synthes GmbH | HTO | |
| Z-1799-2015 | Class II | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with... | Synthes GmbH | FZX | |
| Z-1235-2017 | Class II | The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The... | Terumo Cardiovascular Systems Corporation | KFM | |
| Z-2210-2015 | Class II | Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | JDW | |
| Z-2075-2015 | Class II | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments... | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | HXY | |
| Z-2050-2015 | Class III | PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen)... | Bard Access Systems, Inc. | LJS | |
| Z-2049-2015 | Class III | PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with... | Bard Access Systems, Inc. | LJS | |
| Z-2048-2015 | Class III | PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with... | Bard Access Systems, Inc. | LJS | |
| Z-2047-2015 | Class III | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with... | Bard Access Systems, Inc. | LJS | |
| Z-2457-2015 | Class II | RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2439-2015 | Class II | PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05... | PTW-Freiburg | IYE | |
| Z-1915-2015 | Class II | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm... | Synthes GmbH | HSB | |
| Z-1815-2015 | Class II | Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting... | Integra LifeSciences Corporation | GWM | |
| Z-2154-2015 | Class II | Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs... | Bausch & Lomb Incorporated | HQL | |
| Z-2153-2015 | Class II | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | Bausch & Lomb Incorporated | HQL | |
| Z-1847-2015 | Class II | Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear... | Medtronic Navigation, Inc | HAW | |
| Z-1813-2015 | Class II | CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and... | Abbott Medical | MEA | |
| Z-2206-2015 | Class II | American Science & Engineering Inc,Gemini Cabinet X-ray system. | American Science and Engineering, Inc. | RCG |